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feb81cc0013eea3da959e08b75aa1238

Xpert® MTB/XDR

CEPHEID·III·Ecuador ARCSA·Registered January 05, 2022
Device classification
Risk class
III
Product type
In Vitro Diagnostic
Brand name
Xpert®
Commercial name
21-610.- Reagents/Kits for IVD Assays, Molecular Assay, Infection, Bacteria, Mycobacterium tuberculosis, DNA
Sterilization method
METHODOLOGY: MOLECULAR BIOLOGY
Registration information
Analysis ID
feb81cc0013eea3da959e08b75aa1238
Registration date
January 05, 2022
Expiration date
January 05, 2027
Creation date
May 01, 2022
Manufacturer
Name
CEPHEID
City
SUNNYVALE, CA
Country
UNITED STATES
Address
904 CARIBBEAN DRIVE SUNNYVALE CA, 94089 USA
Product owner
Name
CEPHEID AB
Country
SWEDEN
Authorized representative
Name
HEALTH SYSTEMS ROCARSYSTEM S.A.
Address
TODOS LOS SANTOS # 201 AND AV. JORGE PEREZ CONCHA
Phone
2610680
Product use

FOR DNA DETECTION OF THE MYCOBACTERIUM TUBERCULOSIS (MTB) WITH EXTENSIVE DRUG RESISTANCE (XDR) IN RAW SPUTUM SAMPLES, IN CONCENTRATED SEDIMENTS PREPARED FROM SPUTUM OR IN CULTURE WITH BD™ MYCOBACTERIAL GROWTH INDICATOR TUBE (MGIT).™

About this record

Access comprehensive regulatory information for Xpert® MTB/XDR in the Ecuador medical device market through Pure Global AI's free database. This III medical device is registered under ARCSA ID feb81cc0013eea3da959e08b75aa1238 and manufactured by CEPHEID. The device was registered on January 05, 2022.

This page provides complete registration details including product type (In Vitro Diagnostic), manufacturer information, authorized representative details, and regulatory compliance data from the official Ecuador ARCSA medical device database. Pure Global AI offers free access to Ecuador's complete medical device registry.